Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
The Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety is a Class 2 neurology device that provides low-level electrical current to the head to treat insomnia and/or anxiety. It requires 510(k) clearance and is regulated under 21 CFR 882.5800 within the Neurology medical specialty. The product code is QJQ. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QJQ
- Device Class
- FDA class 2
- Regulation Number
- 882.5800
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
To provide electrical current to the head to treat insomnia and/or anxiety
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 19 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252951 | Genesis Sleep | Dec 31, 2025 | Substantially Equivalent | Neurofield, Inc. |
| K232253 | Modius Stress | Mar 27, 2024 | Substantially Equivalent | Neurovalens Limited |
| K230826 | Modius Sleep | Oct 27, 2023 | Substantially Equivalent | Neurovalens , Ltd. |
| K182311 | Cervella | Mar 07, 2019 | Substantially Equivalent | Innovative Neurological Devices, LLC |
| K090052 | CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C | May 29, 2009 | Substantially Equivalent | Johari Digital Healthcare , Ltd. |
| K070412 | ELEXOMA MEDIC | May 21, 2008 | Substantially Equivalent | Redplane AG |
| K062284 | CES ULTRA | Apr 05, 2007 | Substantially Equivalent | Neuro-Fitness, LLC |
| K060158 | NET-2000 MICROCURRENT STIMULATOR | Oct 13, 2006 | Substantially Equivalent | Auri-Stem Medical, Inc. |
| K024377 | TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1 | Jul 21, 2003 | Substantially Equivalent | Kalaco Scientific, Inc. |
| K932050 | NH-2002 | Jun 05, 1995 | Substantially Equivalent | New Horizon Health Care |
| K910616 | LB-2000 CRANIAL ELECTROTHERAPY STIMULATOR | May 12, 1992 | Substantially Equivalent | Life Balance Intl., Inc. |
| K903014 | ALPHA-STIM CS | May 12, 1992 | Substantially Equivalent | Electromedical Products, Inc. |
| K903654 | LISS CRANIAL STIMULATOR MODEL SBL202-B | Oct 04, 1990 | Substantially Equivalent | Medical Consultants Intl. , Ltd. |
| K894515 | LISS CRANIAL STIMULATOR MODEL SBL201-M | May 03, 1990 | Substantially Equivalent | Medical Consultants Intl. , Ltd. |
| K895175 | NF-1 MINDPEACE | Nov 08, 1989 | Substantially Equivalent | Neurofitness |
| K894097 | NTI-1000 | Sep 25, 1989 | Substantially Equivalent | Neurotek, Inc. |
| K883812 | HP-1 (HEALTHPAX) | Nov 28, 1988 | Substantially Equivalent | Healthdirections, Inc. |
| K873920 | BR-2 BIOREST | Dec 29, 1987 | Substantially Equivalent for Some Indications | Biorest, Inc. |
| K771534 | BIOTRON 18 | Aug 26, 1977 | Substantially Equivalent | Biotronics Corp. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.